Methods and apparatus for light therapy

ABSTRACT

In a first aspect, an apparatus for use in light therapy is provided that includes (1) at least one light emitting diode array adapted to emit a wavelength of light; and (2) a targeting mechanism coupled to the at least one light emitting diode array so as to allow light emitted from the at least one light emitting diode array to be repeatably positioned on a target area during non-contact light therapy. Numerous other aspects are provided.

This application is a continuation of U.S. patent application Ser. No.10/613,608 filed Jul. 3, 2003, which claims priority from U.S.Provisional Patent Application Ser. No. 60/393,607, filed Jul. 3, 2002and U.S. Provisional Patent Application Ser. No. 60/430,269, filed Dec.2, 2002. Each of the above applications is hereby incorporated byreference herein in its entirety.

FIELD OF THE INVENTION

The present invention relates generally to the use of electromagneticenergy during medical treatment, and more particularly to methods andapparatus for light therapy.

BACKGROUND OF THE INVENTION

Visible and near infrared wavelength light is known to have manytherapeutic benefits. For example, wavelengths of 680, 730 and/or 880nanometers have been shown to increase cell growth and speed woundhealing (especially when combined with hyperbaric oxygen), and have beenused to activate photoactive agents for various cancer treatments.Whelan et al., “NASA Light Emitting Diode Medical Applications From DeepSpace to Deep Sea,” Space Technology and Applications InternationalForum—2001, American Institute of Physics, pp. 35-45 (2001).

Despite the recognition of the benefits of visible and near infraredwavelength light irradiation, there remains a need for methods andapparatus for carrying out these and other forms of light therapy.

SUMMARY OF THE INVENTION

In a first aspect of the invention, an apparatus for use in lighttherapy is provided that includes (1) at least one light emitting diodearray adapted to emit a wavelength of light; and (2) a targetingmechanism coupled to the at least one light emitting diode array so asto allow light emitted from the at least one light emitting diode arrayto be repeatably positioned on a target area during non-contact lighttherapy.

In a second aspect of the invention, an apparatus for use in lighttherapy is provided that includes (1) at least one light emitting diodearray adapted to emit a wavelength of light; (2) a targeting mechanismthat includes at least one targeting light source coupled to the atleast one light emitting diode array so as to allow light emitted fromthe at least one light emitting diode array to be repeatably positionedon a target area, wherein the targeting light source is adapted to turnoff prior to image recording; and (3) an imaging mechanism adapted toimage the target area.

Numerous other aspects are provided, as are methods and computer programproducts for carrying out these and other aspects of the invention. Eachcomputer program product described herein may be carried by a mediumreadable by a computer (e.g., a carrier wave signal, a floppy disc, acompact disc, a DVD, a hard drive, a random access memory, etc.).

Other features and aspects of the present invention will become morefully apparent from the following detailed description, the appendedclaims and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of a first embodiment of a light therapydevice provided in accordance with the present invention;

FIG. 2 is a flowchart of an exemplary process that may be performed bythe light therapy device of FIG. 1;

FIGS. 3A-B are a schematic bottom view and side view, respectively, ofan exemplary embodiment of the light therapy device of FIG. 1;

FIG. 4A illustrates an exemplary split screen interface provided inaccordance with the present invention;

FIG. 4B illustrates an exemplary overlay screen interface provided inaccordance with the present invention;

FIG. 5A is schematic side perspective view of an alternative embodimentof the light therapy device of FIGS. 3A and 3B;

FIG. 5B is a schematic bottom view of the light array of FIG. 5A;

FIG. 5C is an enlarged view of the targeting laser and the camera ofFIG. 5A;

FIG. 5D is a schematic top view of the LED array of FIG. 5A;

FIGS. 5E-G are schematic side, front and back views, respectively, of anexemplary embodiment of the interface of FIG. 5A;

FIGS. 5H and 5I are a top schematic view and a side schematic view,respectively, of an embodiment of the LED array of FIG. 5A; and

FIG. 6 is a schematic diagram of an exemplary embodiment of an inventivewound documentation system provided in accordance with the presentinvention.

DETAILED DESCRIPTION

FIG. 1 is a block diagram of a first embodiment of a light therapydevice 100 provided in accordance with the present invention. Withreference to FIG. 1, the light therapy device 100 includes a lightemitting diode (LED) array 102 in communication with a programmablepower source 104, and a user device 106 in communication with theprogrammable power source 104. The light therapy device 100 also mayinclude one or more of a position adjustment device 108, a camera 110and a targeting mechanism 112. As will be described further below, thelight therapy device 100 allows for non-invasive, repeatable dose lighttherapy of a target area (e.g., target tissue 114 in FIG. 1) using oneor more wavelengths of light. Such light therapy may employed, forexample, to stimulate new growth in chronic wounds, to kill pathogenicorganisms, to activate photo sensitive chemicals for treatment of skinor other cancers, or for any similar purpose.

With reference to FIG. 1, the LED array 102 comprises a plurality ofLEDs (not separately shown in FIG. 1) each adapted to emit light withina predetermined wavelength range (e.g., about a specific centerfrequency or wavelength). The LEDs of the LED array 102 may be adaptedto emit the same wavelength, or one or more different wavelengths. In atleast one embodiment of the invention described below with reference toFIGS. 3A-B, the LED array 102 comprises a plurality of sub-arrays eachadapted to emit a different wavelength. For example, one sub-array ofLEDs may be adapted to emit near-infrared light (e.g., light having awavelength within the range from about 1000 to 800 nanometers), onesub-array of LEDs may be adapted to emit visible light (e.g., lighthaving a wavelength within the range from about 800 to 400 nanometers),and another sub-array of LEDs may be adapted to emit ultraviolet light(e.g., light having a wavelength within the range from about 400 to 200nanometers). Other combinations and numbers of wavelengths of light maybe employed, as may other wavelength ranges. The LEDs employed withinthe LED array 102 may comprise any conventional light emitting diodesadapted to emit light of the desired wavelength/frequency.

The programmable power source 104 may comprise any conventional powersource capable of driving the LEDs of the LED array 102 (e.g., any powersource capable of providing one or more driving voltages and/or currentswith a desired amplitude, frequency, duration and/or duty cycle to theLEDs). In one embodiment of the invention, the programmable power source104 comprises a model No. MS210 four-channel mixer and a model no. PS24twenty-four volt power supply available from Advanced Illumination ofRochester, Vt., although any other programmable power source may besimilarly employed. A non-programmable power source also may beemployed.

The user device 106 may comprise, for example, a desktop computer, alaptop computer, a microcontroller, a personal digital assistant (PDA),a keyboard or other interface to the programmable power source 104 orthe like. In at least one embodiment of the invention, the user device106 is adapted to interface with and control the programmable powersource 104 (e.g., by allowing a user to specify the amplitude,frequency, duty cycle and/or duration of one or more power signalsapplied to the LED array 102 by the power source 104). The user device106 also may be employed to control one or more of the positionadjustment mechanism 108, the camera 110 and/or the targeting mechanism112.

The position adjustment mechanism 108 may comprise any mechanism capableof repeatably positioning the LED array 102 relative to a target such asthe target tissue 114. In the embodiment of the light therapy device 100described below with reference to FIGS. 3A-B, the position adjustmentmechanism 108 comprises an articulated arm. Any other conventionalpositioning device may be similarly employed for the position adjustmentmechanism 108, such as an x-y-z stage (with or without motorizedcontrol), a slideable rail system, etc.

The camera 110 may comprise any conventional imaging system for viewinga target area such as the target tissue 114. For example, the camera 110may comprise a digital or analog (film) camera, a charge-coupled device,a digital or analog video system or the like. In at least one embodimentof the invention, the camera 110 comprises a digital camera capable ofcapturing images of a target area for storage and/or manipulation by theuser device 106 (e.g., in a TIF, JPEG or other known format).

The targeting mechanism 112 may comprise any mechanism that allows lightbeams emitted from the LED array 102 to be repeatably positioned on atarget area such as the target tissue 114. In the embodiment of FIGS.3A-B, the targeting mechanism 112 comprises one or more lasers forgenerating one or more light beams on a target area (e.g., one or morevisible light beams). The one or more light beams may be used, forexample, to identify the outermost area irradiated by the LED array 102.Other suitable targeting mechanisms may include, for example,crosshairs, viewfinders, etc.

The position adjustment mechanism 108, the camera 110 and/or thetargeting mechanism 112 may operate independently, or in cooperation, soas to form an overall target positioning system that may or may not bein communication with the user device 106. Those skilled in the art willunderstand that devices in communication with each other need only be“capable of” communicating with each other and need not be continuallytransmitting data to or receiving data from each other. On the contrary,such devices need only transmit data to or receive data from each otheras necessary, and may actually refrain from exchanging data most thetime. Further, devices may be in communication even though steps may berequired to establish a communication link. Such communication may beperformed over any suitable channel or combination of channels includingfor example, wireless, hardwired, optical or other channel types.

Although not shown in FIG. 1, the light therapy device 100 may includeone or more focusing devices for focusing light emitted from the LEDarray (identified by reference numeral 116 in FIG. 1) onto a targetarea. Such focusing devices are well known, and may include, forexample, one or more appropriately selected optical components such as alens.

FIG. 2 is a flowchart of an exemplary process 200 that may be performedby the light therapy device 100 of FIG. 1. One or more of the steps ofthe process 200 may be implemented as one or more computer programproducts stored, for example, in the user device 106.

With reference to FIG. 2, the process 200 begins with step 201. In step202, the LED array 102 is positioned relative to the target area (e.g.,target tissue 114). Positioning of the LED array 102 may be achieved byemploying one or more of the position adjustment mechanism 108, thecamera 110 and the targeting mechanism 112 (as described further below).Following positioning of the LED array 102, the camera 110 may beemployed to image the target area. In an embodiment wherein thetargeting mechanisms 112 includes one or more targeting lasers forpositioning and/or ranging (as described below with reference to FIGS.3A and 3B), laser beam features such as intersection points, crosshairsor the like may be imaged with the target area (e.g., to aid inrepeatable positioning of the LED array 102 relative to the target areaat a later time).

In step 203, a wavelength and dosage of light therapy is selected. Thismay be performed, for example, via the user device 106 and/or theprogrammable power source 104. Assuming the LED array 102 is capable ofproducing multiple wavelengths via a plurality of LED sub-arrays (e.g.,each sub-array generating a different wavelength), the programmablepower source 104 may be configured to independently drive each sub-arrayof LEDs. In the embodiment of the invention described below withreference to FIGS. 3A-B, this is achieved by associating each sub-arrayof LEDs with a different, programmable channel of the programmable powersource 104.

Employing either the user device 106 or the programmable power source104, a user may select a wavelength of light with which to irradiate atarget area, and the dose of the light to deliver. Dose may be set viaselection of amplitude, duty cycle and/or duration of the power signalor signals used to drive the LEDs which generate the selected wavelengthof light. In at least one embodiment, the user device 106 may beprovided with dose recipes which represent predetermined power signalamplitudes, duty cycles and/or durations for one or more light doses.Accordingly, a user need only select a desired dose without having todetermine power signal amplitude, duty cycle, duration or the like.

Once a wavelength and dosage of light therapy has been selected, in step204 the target area is irradiated with the selected wavelength anddosage (e.g., via application of the appropriate power signal or signalsto the LED array 102 via the programmable power source 104).

In step 205, it is determined whether any other wavelengths or doses oflight therapy are to be applied to the target area. If so, the process200 returns to step 203 for selection of the next wavelength and/ordosage of light therapy; otherwise the process 200 ends in step 206.Note, the process 200 may include a step of documenting the performedlight therapy such as taking one or more images of the target area,recording dose or exposure information, etc., with the user device 106.

It will be understood that multiple wavelengths may be applied (e.g.,simultaneously) during step 204, and that wavelength selection may occurprior to positioning of the LED array 102.

FIGS. 3A and 3B are a schematic bottom view and side view, respectively,of an exemplary embodiment of the light therapy device 100 of FIG. 1(referred to by reference numeral 100′ in FIGS. 3A-B). As will bedescribed further below, the light therapy device 100′ of FIGS. 3A-B mayprovide clinically repeatable dosages of near infrared (NIR),ultra-violet (UV) and other light frequencies to stimulate new growth inchronic wounds, to kill pathogenic organisms, to activate photosensitive chemicals in the treatment of skin and other cancers, etc.

In the embodiment of FIGS. 3A and 3B, the light therapy device 100′employs four different LED wavelengths within the range from about 200to 1000 nanometers. It will be understood that in general, any number ofindependently controlled LED wavelengths may be employed (e.g., forspecific clinical applications), and that other wavelengths may beemployed.

With reference to FIG. 3A, the light therapy device 100′ includes an LEDarray 102′ having one-hundred twenty LEDs 302 (not all one-hundredtwenty of which are illustrated in FIG. 3A) configured in a circulararrangement. The LED array 102′ is divided into four sub-arrays (notseparately shown) of LEDs which emit four different wavelengths(frequencies). In at least one embodiment, the four wavelengths emittedby the four LED sub-arrays are 350, 590, 660, and 880 nanometers,although other wavelengths may be employed. The shorter wavelengths maybe desirable as 590 nm may provide the shorter wavelength needed toresonate low molecular weight growth factors, and 350 nm is aphotochemical frequency responsible for the production of Vitamin D3 andmelanin in human skin and is known to be moderately pathogenic to mostinfecting organisms.

Each of the four LED sub-arrays represents an isolated circuit of 30LEDs, 29 of which are arranged in a 360-degree pattern of lightdistribution that is equal as compared to the other LED sub-arraypatterns for uniform light distribution to a circular, rectangular orotherwise shaped target area (e.g., a tissue target area 114′ in FIG.3B). That is, LED's of differing frequencies are uniformlyinterdispersed (rather than having all LED's of the same frequency beinggrouped together). The remaining (one) LED of each sub-array is disposedon a backside of the LED array 102′ and may be employed as an indicatorlight to identify when power is being applied to each LED sub-array.Such an LED array may be similar to a model no. CL 141A-4 Color RL361205” Ring Light available from Advanced Illumination but customized forthe particular wavelengths being employed. Other LED arrays may beemployed.

In at least one embodiment, the LED array 102′ is arranged in a nearflat circular plane that is directed and/or focused to a 150 mm per sidesquare target when the LED array 102′ is positioned at a distance 303 of300 mm from a target area (e.g., tissue target area 114′). In such anembodiment, the outside diameter of the LED array 102′ may be about 128mm in diameter with an interior circular opening 305 of about 50 mm.Other LED array shapes, sizes, focal lengths and focal widths may beemployed.

A four channel programmable power source 104′ (e.g., a four channelprogrammable controller, a programmable voltage source, amicrocontroller, or the like) is provided that can vary both the powersignal applied to each 30 unit LED circuit/sub-array. For example, theprogrammable power source 104′ may vary one or more of the voltage,current, amplitude, duty cycle, duration, etc., applied to each LEDcircuit/sub-array. This feature permits controlled tissue “dosing” witheach individual LED wavelength, or a specific pattern of wavelengthexposure in order to provide the optimal exposure to promote growth,fight infection, or activate photodynamic compounds. In at least oneembodiment, the power source 104′ may be programmed via a user devicesuch as a laptop or other computer 106′

As shown in both FIGS. 3A and 3B, the light therapy device 100′ isequipped with a target positioning system 304 that includes lasers 308a-d, a camera 110′ (e.g., a digital camera) and a computer basedprogrammable controller and text/photo documentation system (e.g., oneor more software programs operable with the laptop or other computer106′). For example, the computer 106′ may record and/or store patientmedical information, wound measurements, wound photographs (e.g.,provided via the camera 110′) and repeatable dosage exposures of thewound or wounds of each patient being treated.

In one embodiment of the invention designed for multiple wounds in onearea, the outer perimeter of the LED array 102′ employs four 400-700nanometer lasers 308 a-d placed 90 degrees apart and each having anoutput power of less than about 1 milliwatt. Other targeting laserwavelengths and powers may be employed. Targeting lasers are widelyavailable and may be obtained, for example, from Edmund Scientific.

The two vertical lasers (0 and 180 degree lasers—lasers 308 b and 308 din FIG. 3A) may be “ranging” lasers adjusted so that their output beamsintersect on a target area, such as the tissue target area 114′, whenthe LED array 102′ is positioned a predetermined distance from thetarget area (e.g., at 300 mm). The two horizontal lasers (90 and 270degree lasers—lasers 308 a and 308 c in FIG. 3A) may be “positioning”lasers adjusted to produce two beams on the target area which areseparated by a predetermined distance (e.g., 150 mm, 200 mm, 300 mm,etc.) when the ranging lasers 308 b, 308 d intersect (e.g., when the LEDarray 102′ is the predetermined distance from the target area). Othernumbers of ranging and positioning lasers may be employed, as may otherlaser wavelengths, spacings, intersection distances and positioningdistances.

In another embodiment designed for large single wounds, a single laserthat projects cross-hair 90 degree intersecting beams may be employed toprovide simultaneous “ranging” and “positioning” beams that operate inessentially the same manner as the four laser embodiment describedpreviously. For example, a single crosshair laser may be adjusted toproduce crosshairs of a predetermined length (e.g., 150 mm, 200 mm, 300mm, etc.) on the target area when the laser is positioned at apredetermined distance from the target area (e.g., 300 mm). When such alaser is employed, the target area may be delineated, for example, by anindelible marker with cross hairs spaced at the predetermined length(e.g., 150 mm) so that the crosshairs of the laser align with the targetarea delineations when the laser is positioned the predetermineddistance from the target area (e.g., 300 mm). Other targeting techniquesmay be employed for ensuring accurate placement of the LED array.

As best shown in FIG. 3A, in at least one embodiment of the invention,the camera 110′ is a charge coupled device (CCD) based digital camerathat is located in an interior opening 310 of the LED array 102′. Forexample, the camera 110′ may be a Quick-Cam Pro 3000 available fromLogitech or another similar camera. The camera 110′ may be pre-focusedto permit retargeting and digital photo documentation of the sametissue/wound site. Further within this embodiment, one or more softwareprograms stored within the computer 106′ and the camera 110′ may form adigital photo system that permits wound areas to be compared andrepresented as a percentage or square centimeter change in wound area todocument healing. A slide show sequencing of overlay photographs overtime may be employed to demonstrate stages of healing. Software also maybe employed to permit a sequence of photographs to be “morphed” togetherinto a continuous motion.

The LED array 102′ and target positioning system 304 may be mounted onan articulating arm 108′ that permits the LED array 102′ to bepositioned over a target area (e.g., 300 mm or another relevant distanceover a patient's wound site in the above example) without physicalcontact. The programmable power source 104′ and/or the computer 106′ maybe connected to the arm 108′ and LED array 102′ by one or more cables312. Wireless connectivity also may be employed. In at least oneembodiment, a 12-volt battery or a 120/240 VAC power supply powers theentire system.

Once the light therapy device 100′ has been accurately placed over atarget area such as the tissue target area 114′, the target area (e.g.,tissue/wound) may be photographed and the computer 106′ may direct theprogrammable power source 104′ to provide a specific series orcombination of wavelengths/frequencies and intensities/durations (e.g.,dosages) of LED light to the target area.

In at least one embodiment of the invention, the LED array 102′ isplaced about 300 mm above the target area (e.g., a wound area to beexposed); and the lasers beams 307 a, 307 b (shown in the plane of FIG.3B for reference purposes) from the ranging lasers 308 b, 308 d areplaced to intersect at the proximal center 316 of the wound area. Thepositioning lasers 308 a, 308 c are adjusted horizontally so that theiroutput beams 309 a, 309 b “straddle” the wound area on normal tissuethat has been “marked” (e.g., with an indelible marker used to mark skinin plastic surgery) as shown by crosses 314 a-b. Repeatable tissuedosing, dimensioning and photography thereby is ensured.

The target positioning system 304 thus allows repeatable placement ofthe LED array 102′ relative to a target area such as a chronic wound ortargeted tissues to facilitate repeatable LED dosages, photographs,wound measurements and text narrative to document clinical progress. Arepeatable clinical dosing system for delivering a number offrequencies, intensities, and a repeatable duration of exposure therebyis provided.

With use of the embodiments of the present invention, sequencing of eachof the four (or more) wavelengths in relation to each other ispermitted. The invention also provides for complete repeatable dosagecontrol for each exposure as well as a complete dosage record for eachpatient. The foregoing description discloses only exemplary embodimentsof the invention. Modifications of the above disclosed apparatus andmethod which fall within the scope of the invention will be readilyapparent to those of ordinary skill in the art. For instance, instead ofemploying LEDs as light sources, lasers or other light sources may beemployed. Other wavelengths than those described may be employed. Forexample, in one embodiment, the following wavelengths may be employed:625 nm, 660 nm, 735 nm and 880 nm.

Indicator lights (not shown) may be mounted on the back of the LED array102′ to indicate which LED circuit/sub-array has been activated.

In an least one embodiment, a CCD-type color camera may be employed asthe camera 110′. The camera may be mounted inside the LED array 102′,and a single cross hair laser may be positioned underneath the cameraand tilted to intersect the crosshairs at the center of a TV camerafield. Split screen software then may be employed on the computer 106′to allow a user to position a previously recorded image next to arealtime image. When the position of both images match, the realtimeimage may be recorded. Overlaying the images allows a user to observewound healing.

FIG. 4A illustrates an exemplary split screen interface 400 provided inaccordance with the present invention. The split screen interface 400may be displayed, for example, on a screen of the user device 106 (e.g.,a laptop or other computer such as the computer 106′); and may beimplemented via one or more computer program products stored, forexample, in the user device 106.

With reference to FIG. 4A, the split screen interface 400 employs awindow 402 having a first viewing area 404 a and a second viewing area404 b. The first viewing area 404 a is adapted to display a previouslyrecorded image (e.g., an “historical” image) of a target area A (e.g.,as captured by the camera 110) and the second viewing area 404 b isadapted to display a realtime image of the target area A (e.g., ascaptured by the camera 110). The positioning of the historical andrealtime images may be reversed. For clarity, reference numerals of likeitems within the second viewing area 404 b (the realtime image area)will be differentiated with a single apostrophe.

In the embodiment of FIG. 4A, the target area A includes a wound 406(406′) that has been delineated by indelible markings 408 a, 408 b (408a′, 408 b′). Note that the image of the crosshairs of a targeting laser(e.g., a single crosshair laser) are also recorded by the camera 110 asindicated by reference numerals 410 a, 410 b (410 a′, 410 b′). In atleast one embodiment, the crosshairs 410 a, 410 b (410 a′, 410 b′) havea predetermined length (e.g., 150 mm) when the LED array 102 ispositioned a predetermined distance (e.g., 300 mm) above the targetarea. In the embodiment of FIG. 4A, the markings 408 a, 408 b (408 a′,408 b′) are spaced 150 mm apart. In this manner, a repeatable distancemay be maintained between the target area and the LED array 102 merelyby ensuring that the crosshair 410 b (410 b′) contacts both markings 408a, 408 b (408 a′, 408 b′).

As shown in FIG. 4A, the split screen interface 400 allows for easycomparison of a previously recorded image of the target area A (viewingarea 404 a) with a realtime image of the target area A (viewing area 404b). Wound size thereby may be easily compared (e.g., to determinehealing progress/rate). In at least one embodiment, proper positioningof the LED array 102 may be determined by contacting an end of thehistorical image crosshair 410 b with an end of the realtime imagecrosshair 410 b′ (as shown). Software preferably allows for calculationof wound area within the viewing areas 404 a, 404 b (e.g., to furtheraid in tracking healing). Various information such as wound area size412 (412′), patient information 414 (414′) or the like may be displayedwithin one or more of the viewing areas 404 a, 404 b.

FIG. 4B illustrates an exemplary overlay screen interface 450 providedin accordance with the present invention. The overlay screen interface450 may be displayed, for example, on a screen of the user device 106(e.g., a laptop or other computer such as the computer 106′); and may beimplemented via one or more computer program products stored, forexample, in the user device 106.

The overlay screen interface 450 is similar to the split screeninterface 400, but overlays the realtime image on the historical imageas shown. Differences in wound area thereby are more readily observable,and positioning is simplified as proper positioning/alignment may beassured merely by overlaying historical image crosshairs 410 a, 410 bover realtime image crosshairs 410 a′, 410 b′. Other user interfaces maybe employed. Patient information (not shown), wound area information452, etc., also may be displayed by the overlay screen interface 450.

As an example, a real-time image of a smaller wound (5×8 cm=40 cm²) canbe superimposed over a larger historical wound image so that both can beseen for comparison by moving the real-time LASER crosshair to cover thecrosshair image from the historical image. This aligns the real-timeimage directly over the historical image for comparison. Any number ofimages may be “layered” on top of each other in a slideshow format, andslowly or rapidly sequenced from the oldest to the latest image.Software may be employed to compare and calculate a square centimeter(or other unit) area comparison between the historical and real-timeimages. This may be accomplished, for example, by “marking” theperimeter of the wound. The software then may compare the number ofdarker pixels inside the wound perimeter to the number of lighter pixelsoutside the wound perimeter. All images may be time/date stamped andsaved as a retrievable file. In at least one embodiment, an image of atarget area may not be saved without a patient number foridentification.

The above described patient photo documentation system may also permitthe historical and real-time images to be placed side by side forcomparison (as shown in FIG. 4A). The historical image is placed on oneside of a screen and the real-time image is placed on the other side ofthe screen. The real time image may be aligned using a LASER crosshairby connecting a horizontal LASER line of each image end to end.

Though the present invention has been described primarily with referenceto non-contact applications (e.g., for sterility purposes), it will beunderstood that the LED array 102 (or 102′) may be placed in contactwith a target area. For example, the LED array may be implemented as aflexible (e.g., rubber pad) array, placed in a disposable container(e.g., a plastic bag) and placed directly on a wound site.

FIG. 5A is schematic side perspective view of an alternative embodimentof the light therapy device 100′ of FIGS. 3A and 3B (referred to byreference numeral 100″ in FIG. 5A). The light therapy device 100″ ofFIG. 5A may be similar to the light therapy device 100′ of FIGS. 3A-3Band include, for example, the LED array 102′, a programmable controllerand/or power source similar to programmable controller 104′ of FIGS.3A-3B (represented as interface 502 in FIG. 5A) and a user device suchas the computer 106′ (shown as a laptop computer in FIG. 5A, althoughany other computer may be employed). The computer 106′, for example, maycontrol operation of the light therapy device 100″ (e.g., as previouslydescribed with reference to the light therapy device 100′ of FIGS.3A-3B).

The light therapy device 100″ of FIG. 5A includes the target positioningsystem 304 of the light therapy device 100′ of FIGS. 3A and 3B, which inthe embodiment shown in FIG. 5A, includes a single targeting laser 504(e.g., a single, crosshair laser), the camera 110′ and in someembodiments a computer based text/photo documentation system (e.g., oneor more software programs operable with the laptop or other computer106′). The articulating arm 108′ or another position adjustmentmechanism also may be employed (as previously described).

The light therapy device 100″ may include a power source 506 (that maybe coupled to the LED array 102′) for supplying power to the targetinglaser 504 (e.g., via a power cord 508). An external power source alsomay be used. Preferably a switch 510 is provided that allows thetargeting laser 504 to be turned on during positioning of the LED array102′ and turned off after positioning of the LED array 102′, prior toemploying the camera 110′ to record an image of a target area. Otherconfigurations may be employed. For example, the computer 106′ may beused to automatically turn off the targeting laser 504 prior to imagerecording (e.g., instead of employing the switch 510). In some cases, itmay be desirable to leave the targeting laser 504 on during imagerecording.

Further views of portions of the light therapy device 100″ are shown inFIG. 5B which is a schematic bottom view of the light array 102′ of FIG.5A; FIG. 5C which is an enlarged view of the targeting laser 504 and thecamera 110′ of FIG. 5A; FIG. 5D which is a schematic top view of the LEDarray 102′ of FIG. 5A; and FIGS. 5E-G which are schematic side, frontand back views, respectively, of an exemplary embodiment of theinterface 502.

FIGS. 5H and 5I are a top schematic view and a side schematic view,respectively, of an embodiment of the LED array 102′ of FIG. 5A whereinthe LED array 102′ is divided into four LED sub-arrays 512 a-d. In atleast one embodiment, each sub-array is adapted to output a uniquewavelength (e.g., 350, 590, 660 and 880 nanometers, although otherfrequencies may be employed). Other numbers of LED sub-arrays and otherLED arrangements may be used. For example, LED's that output the samewavelength of light need not be grouped together (as previouslydescribed with reference to the LED array 102′ of FIGS. 3A and 3B).

In at least one embodiment of the invention, each LED sub-array 512 a-dis configured to output and focus light over a predefined area 514 whenthe LED array 102′ is positioned at a predefined height 516 above atarget area 518 (FIG. 5I). In the exemplary embodiment shown in FIGS.5H-I, the predefined area 514 is about 150 mm when the LED array 102′ ispositioned at a predefined height 516 of 300 mm above the target area518. Other predefined areas and/or heights may be employed. Note thatthe light beam of the targeting laser 504, the focus of the camera 110′and the focus of the LED sub-arrays 512 a-d may be configured so as tointersect on the target area 518 within the predefined area 514 when theLED array 102′ is positioned at the predefined height 516 (as shown inFIG. 5I). That is, when the LED array 102′ is positioned at thepredefined height 516, (1) the LED sub-arrays 512 a-d may be configuredto produce focused light beams on the target area 518 within thepredefined area 514; (2) the targeting laser 504 may be configured toproduce a crosshair or other identifying feature that fills, crosses orotherwise aligns with the target area 518 (such as described previouslywith reference to FIGS. 3A-4B); and (3) the camera 110′ may beconfigured to provide a focused image of the predefined area 514.

In an alternative embodiment of the invention, rather than using thecomputer 106′ or the switch 510 to turn off the targeting laser 504, thetargeting laser 504 and/or the camera 110′ may be controlled by anelectronic sequencer such as a multi-position switch (not shown)positioned on the LED array 102′ or at another suitable location. Forexample, in one embodiment, when the multi-position switch is notdepressed, both the targeting laser 504 and the camera 110′ are off (orin a standby mode). When the multi-position switch is slightlydepressed, the targeting laser 504 is turned on, allowing the LED array102′ to be accurately positioned relative to a target area (aspreviously described). When the multi-position switch is fullydepressed, the targeting laser 504 is turned off, and the camera 110′ isdirected to record an image of the target area. Alternatively, oradditionally, full depression of the multi-position switch may initiatea predetermined dose of light to be delivered to the target area via theLED array 102′.

In one embodiment of the invention, the electronic sequencer, thetargeting laser 504, the camera 110′ and/or the LED array 102′ may workin cooperation with the computer 106′. For example, depression of theelectronic sequencer may signal the computer 106′ to (1) turn on or offthe targeting laser 504; (2) record an image with the camera 110′;and/or (3) direct the LED array 102′ to deliver a predetermined lightdose to a target. Likewise, dedicated control logic (not shown) mayallow/direct the electronic sequencer, the targeting laser 504, thecamera 110′ and/or the LED array 102′ to so operate. Note that any ofthe above described embodiments for the light therapy device 100″ mayoperate in a manner similar to the light therapy device 100′ of FIGS. 3Aand 3B, and may be employed with a split and/or overlay screen interfacein a manner similar to that described with reference to FIGS. 4A and 4B.

In general, repeatable measurements and documentation (e.g., imaging) ofwounds during wound treatment is difficult, whether or not light therapyis employed. For instance, wounds typically are documented weekly andoften by different people using different photography techniques.

The inventive target positioning systems described above may be employedto document any wound treatment (e.g., whether or not light therapy isemployed). Such systems may permit exact positioning of a camerarelative to a wound (e.g., using one or more lasers coupled to thecamera that ensure that the camera is precisely positioned/focusedrelative to a target).

FIG. 6 is schematic diagram of an exemplary embodiment of an inventivewound documentation system 600 provided in accordance with the presentinvention. The wound documentation system 600 comprises a digital (orother suitable) camera 602, and at least one targeting laser 604 and anelectronic sequencer 606 (e.g., a multi-position switch) coupled to thecamera 602. The camera 602 may or may not be coupled to a computer orother controller 608 (e.g., an appropriately programmed laptop ordesktop computer, personal digital assistant, hand held video gameplayer such as a GameBoy™, etc.).

In one embodiment of the invention, the targeting laser 604 comprises acrosshair laser that is affixed to the camera 602 and aligned to focusat a center of the optical field of the camera 602. (Another type oflaser, an LED or some other light source also may be used.) Such acrosshair laser may produce a fan shaped, XY crosshair beam B on atarget area, wherein each beam leg changes length as the camera602/laser 604 are moved toward or away from the target area (as shown inFIG. 6). Other targeting lasers and/or alignment configurations may beemployed.

The electronic sequencer 606 may comprise, for example, a multi-positionswitch. In at least one embodiment, the multi-position switch may be amomentary (e.g., multi-circuit N/O-N/C) three stage switch that allowsthe targeting laser 604 to be turned on to align the camera 602, butturned off prior to image capture by the camera 602 (thereby eliminatingthe laser beam B from any recorded image). For example, themulti-position switch may have:

-   -   (1) a static (e.g., spring biased) position in which the        targeting laser 604 is off (or in standby) and the camera 602 is        off (or in standby);    -   (2) a first detent position in which the targeting laser 604 is        on and the camera 602 is off (or in standby); and    -   (3) a second (e.g., fully depressed) detent position in which        the targeting laser 604 is off and the camera 602 records an        image.        Other configurations may be employed.

In operation, two or more marks or other indicators 610 a-c (three ofwhich are shown in FIG. 6) are made on a perimeter of a wound area 612(e.g., using an indelible dermal marker pencil or other marking device).The two or more marks 610 a-c preferably are placed peri-wound at aknown distance (e.g., 200 mm in one embodiment, although other distancesmay be employed).

Thereafter, the electronic sequencer 606 is depressed to its firstdetent position to turn on the targeting laser 604, and the camera 602,and the targeting laser 604 coupled thereto, are moved toward or awayfrom the marks 610 a-c until the crosshairs of the laser beam B alignexactly between the marks 610 a-c. Once the crosshairs of the laser beamB of the targeting laser 604 are aligned with the marks 610 a-c, theelectronic sequencer 606 may be depressed (e.g., further) to the seconddetent position so as to turn off the targeting laser 604 and record animage with the camera 602.

The camera 602, the targeting laser 604 and/or the entire wounddocumentation system 600 may be self contained and may, for example,employ a diskette, memory chip or other storage medium for imagestorage. In the embodiment shown in FIG. 6, the camera 602 is coupled tothe computer 608 which may be equipped with a larger memory system anddigital imaging software in order to add patient information (e.g.,name) to a photo/image, print pictures for inclusion in a medical chartor the like. The system 600 also may scale wound X-Y dimensions and areausing the known distance between the markings 610 a-c. The wounddocumentation system 600 may employ a split and/or overlay screeninterface in a manner similar to that described with reference to FIGS.4A and 4B (e.g., to allow side-by-side or overlap time lapsed sequencingof wound treatment/healing images).

Fewer or more marks 610 a-c than described may be used (e.g., one ortwo, more than three, etc.). An articulating arm or other positioningmechanism may be employed with the wound documentation system 600 toassist in positioning of the camera 602. (Likewise, an articulating armneed not be employed with any of the light therapy devices describedherein).

Accordingly, while the present invention has been disclosed inconnection with exemplary embodiments thereof, it should be understoodthat other embodiments may fall within the spirit and scope of theinvention, as defined by the following claims.

1. An apparatus for use in light therapy comprising: at least one lightemitting diode array adapted to emit a wavelength of light; and atargeting mechanism coupled to the at least one light emitting diodearray so as to allow light emitted from the at least one light emittingdiode array to be repeatably positioned on a target area duringnon-contact light therapy.
 2. The apparatus of claim 1 wherein the atleast one light emitting diode array comprises a plurality of lightemitting diode arrays, each light emitting diode array adapted to emit adifferent wavelength of light.
 3. The apparatus of claim 2 wherein eachlight emitting diode array includes a plurality of light emitting diodesand wherein light emitting diodes that emit different wavelengths areuniformly interdispersed.
 4. The apparatus of claim 3 wherein each lightemitting diode is adapted to emit a wavelength of 625 nm, 660 nm, 735 nmor 880 nm.
 5. The apparatus of claim 3 wherein each light emitting diodeis adapted to emit a wavelength of 350, 590, 660 or 880 nanometers. 6.The apparatus of claim 1 further comprising a positioning device coupledto the at least one light emitting diode array and adapted to positionthe at least one light emitting diode array relative to a target area.7. The apparatus of claim 1 further comprising an imaging mechanismadapted to record an image of a target area.
 8. The apparatus of claim 7wherein the targeting mechanism is coupled to the imaging mechanism andincludes at least one targeting light source, the at least one targetinglight source adapted to allow the imaging mechanism to be repeatablypositioned relative to a target area prior to image recording.
 9. Theapparatus of claim 8 further comprising a sequencer mechanism having: afirst position in which the at least one targeting light source is offand the imaging mechanism does not record an image; a second position inwhich the targeting light source is on and the imaging mechanism doesnot record an image; and a third position in which the targeting lightsource is off and the imaging mechanism records an image.
 10. Anapparatus for use in light therapy comprising: at least one lightemitting diode array adapted to emit a wavelength of light; a targetingmechanism that includes at least one targeting light source coupled tothe at least one light emitting diode array so as to allow light emittedfrom the at least one light emitting diode array to be repeatablypositioned on a target area, wherein the targeting light source isadapted to turn off prior to image recording; and an imaging mechanismadapted to image the target area.
 11. A method of light therapycomprising: providing an apparatus for use in light therapy having: atleast one light emitting diode array adapted to emit a wavelength oflight; and a targeting mechanism coupled to the at least one lightemitting diode array so as to allow light emitted from the at least onelight emitting diode array to be repeatably positioned on a target areaduring non-contact light therapy; positioning the at least one lightemitting array relative to a target area; selecting a wavelength and adosage of light therapy; and irradiating the target area with theselected wavelength and dosage.